Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon

NCT02591225 | Unknown Phase 4

• 1 other identifier: BI 1160.206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, two treatment groups, open, phase IV clinical study in subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit) subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can be performed followed by randomization to one of the two treatment groups (Phenprocoumon or Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at this visit. If the subject was randomized in the VKA group routinely INR measurements will performed.

Conditions

Atrial Fibrillation; Left Atrial Thrombosis

Keywords

left atrial thrombus size; transesophageale echocardiography; silent cerebral embolism

Outcome Measures

Primary Outcomes (1)

• left atrial thrombus resolution

  thrombus size evaluated by transeshophageal echocardiography

  12 months

Secondary Outcomes (1)

• cerebral emolism

  12 months

Study Arms (2)

Dabigatranetexilate

EXPERIMENTAL

Dabigatran capsula 150 mg; oral; bid; treatment period 12 months

Drug: Dabigatranetexilate

Phenprocoumon

ACTIVE COMPARATOR

Phenprocoumon INR adjusted; oral; once daily; treatment period 12 months

Drug: Phenprocoumon

Interventions

Dabigatranetexilate DRUG

After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.

Also known as: Pradaxa

Dabigatranetexilate

Phenprocoumon DRUG

After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.

Also known as: Marcumar

Phenprocoumon

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed and dated written informed consent
• atrail fibrillation
• left atrial thrombus
• negative pregnancy test in woman with childbearin potentail
• subjects who have the ability to understand and comply the instructions for participation

You may not qualify if:

• low body weight \< 50 kg
• instable cardiac or respiratory condition
• contraindication for Phenprocoumon or Dabigatran
• severely reduced renal function (CrCl \< 30 ml/min)
• inadequate hepatic function (AST and ALT higher than 2 x ULN)
• Contraindication for MRI
• Durg/alcohol abusus
• Pregnant or nursing woman
• subject is an employee of any involved study investigator
• Parallel participation in another clinical trial
• Treatment with another investigational product

Sponsors & Collaborators

• University of Ulm: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Department of Internal Medicine II, University Hospital Ulm

Ulm, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; Phenprocoumon

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Peter Bernhardt, MD

  University Hospital Ulm, Department of Internal Medicine II

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte Ruess

CONTACT

+4973150045250; brigitte.ruess@uniklinik-ulm.de

Uta Dichristin

CONTACT

+4973150045250; uta.dichristin@uniklinik-ulm.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

DE (1)